Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluations, it features 64 new protocols on topics such as sterility assurance, media fill guidelines, and environmental control.
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Book Description
Editorial Reviews
About the Author
Haider; Syed Imtiaz Gulf Pharmaceuticals Industries, United Arab Emirates,
--This text refers to an alternate
Hardcover
edition.
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Most Helpful Customer Reviews
14 of 15 people found the following review helpful:
1.0 out of 5 stars
Sad - this book could have used an Editor,
By
Amazon Verified Purchase(What's this?)
This review is from: Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries, Second Edition (Hardcover)
First of all - no index.Second - the CD has examples that are poorly and inconsistently formatted. To use them, you'd have to spend time formatting everything. They should have used fonts, styles, etc. that are used in standard documents. Thirdly - the book is huge so you'd expect more information on what to put in a Purpose, a Scope, etc. You don't get that. Instead you get a bunch of examples that must have been pulled from one or two companies. If you are a professional writer like me, you don't want to waste time. You want something in template format that you can easily adapt to your company's product. If there had been a review of this - I never would have bought it. I'm sorry but this book could have used an Editor. It was so disappointing and I'm so happy that Amazon understood my feelings and accepted the return of this book. For a potential writer - here is a market! There are startup or small biotech/biomed companies that are trying to meet FDA regulations on SOPs and other related documents. Write a book and provide a CD with decent templates and examples! Hey, maybe I should do that. Good luck. I haven't found any other book that would help either....
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Inside This Book
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Key Phrases - Statistically Improbable Phrases (SIPs):
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stearothermophilus strip, check physical appearance, daily production start, personnel bioburden, sterility during the aseptic processing, challenge aerosol penetration, endotoxin vials, spore bioburden, study including temperature, validation team members, filling machine parts, allowable carryover limit, endotoxin challenge test, validation officer, bioburden method, total aerobic viable count, sanitization records, following documentation requirements, installation qualification review, maximum tunnel speed, vial washing machine, attachment nos, cycle printouts, spiked vials, validation standard operating procedures Key Phrases - Capitalized Phrases (CAPs): (learn more)
Department Signature, Frequency Initial, Section Pages Initials, Floor Floor, Disinfectant Efficacy Analyzed, Interpharm Press, Issue Date, Microbiologist Signature, Station Once, Buffalo Grove, Active Material Solution Testing Ingredient, Location Injectable, Procedure Perform, Recovery of Active, Comments None, Conclusion Acceptance, Deviation None, Documentation Make, Procedure After, Quality Control Department, Results Remarks, Routine Intensive Alert Action Activity Room, Machine Needles, Minor Fill, Provide Twice New!
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Front Cover | Table of Contents | First Pages | Back Cover | Surprise Me!
stearothermophilus strip, check physical appearance, daily production start, personnel bioburden, sterility during the aseptic processing, challenge aerosol penetration, endotoxin vials, spore bioburden, study including temperature, validation team members, filling machine parts, allowable carryover limit, endotoxin challenge test, validation officer, bioburden method, total aerobic viable count, sanitization records, following documentation requirements, installation qualification review, maximum tunnel speed, vial washing machine, attachment nos, cycle printouts, spiked vials, validation standard operating procedures Key Phrases - Capitalized Phrases (CAPs): (learn more)
Department Signature, Frequency Initial, Section Pages Initials, Floor Floor, Disinfectant Efficacy Analyzed, Interpharm Press, Issue Date, Microbiologist Signature, Station Once, Buffalo Grove, Active Material Solution Testing Ingredient, Location Injectable, Procedure Perform, Recovery of Active, Comments None, Conclusion Acceptance, Deviation None, Documentation Make, Procedure After, Quality Control Department, Results Remarks, Routine Intensive Alert Action Activity Room, Machine Needles, Minor Fill, Provide Twice New!
Books on Related Topics | Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Back Cover | Surprise Me!
Citations (learn more)
This book cites 11
books:
See all 11 books this book cites
- Pharmaceutical Process Validation: An International Third Edition (Drugs and the Pharmaceutical Sciences) by Robert A. Nash on page 1116, and page 1117
- Project Management (Harvard Business Review Paperback Series) by Harvard Business Review on page 17
- Validating Automated Manufacturing and Laboratory Applications: Putting Principles into Practice by Guy Wingate on page 1118
- Validation and Qualification in Analytical Laboratories by Ludwig Huber on page 1117
- Good Computer Validation Practices: Common Sense Implementation by Teri Stokes on page 1118
See all 11 books this book cites
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